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Cvprofilor D0-2020 Cardiovascular Profiling System

by Hypertension Diagnostics, Inc.

510(k) K001948

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001948 Date1 Nov 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cvprofilor D0-2020 Cardiovascular Profiling System is a device used for cardiovascular profiling. It is classified under the product code DXN. The device is substantially equivalent and has been reviewed by the Cardiovascular advisory committee.

The Cvprofilor D0-2020 Cardiovascular Profiling System is supplied by Hypertension Diagnostics, Inc. and has received FDA 510K authorization. The device is available with the model number D0-2020, and its storage and usage are subject to standard regulations, with no specific sterility or MRI safety information provided. The system is used in a clinical setting, with the exact usage and storage conditions determined by the manufacturer's instructions and relevant regulatory guidelines.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Cvprofilor D0-2020 used for?

    The Cvprofilor D0-2020 is used for cardiovascular profiling in a clinical setting, with usage and storage determined by the manufacturer's instructions and regulatory guidelines.

  • Is the Cvprofilor D0-2020 sterile?

    No specific sterility information is provided for the Cvprofilor D0-2020, and its storage and usage are subject to standard regulations.

  • What model number is the Cvprofilor D0-2020 available as?

    The Cvprofilor D0-2020 is available with the model number D0-2020.